COVID-19

Sponsors that choose to conduct remote trial monitoring during the COVID-19 crisis should focus on the most critical site documentation and source data and ensure the security of the data by creating a secure electronic viewing portal or using a sponsor-controlled electronic system or cloud-based repository, says an updated guidance the FDA released last week. Read More

As the COVID-19 pandemic pushes sponsors toward conducting remote outcome measures, it’s important for them to ensure that data they gather and the conclusions drawn from them are still valid and reliable. Read More

The impact of COVID-19 on the clinical trials industry will be far-reaching and many of the changes sponsors and sites are making to deal with the coronavirus outbreak will continue to be adopted long after the pandemic is under control. Read More

Global research charity Wellcome Trust is asking CEOs of multinational companies to help raise at least $8 billion by the end of the month to cover a worldwide “funding shortfall” for developing and manufacturing COVID-19 vaccines, treatments and diagnostics. Read More

A global clinical trial based at the University of Pittsburgh School of Medicine (UPSM) is tracking COVID-19 treatment data worldwide and using a machine learning platform to identify the most effective approaches to test on infected patients in its 40-hospital network. Read More

Nearly 1,000 patients with coronavirus in the UK have enrolled in the world’s largest randomized clinical trial of potential COVID-19 treatments. The trial, which has been prioritized and fast-tracked by the UK government, will examine the value of HIV, anti-inflammatory and anti-malarial drugs in fighting the virus. Read More

Sponsors and investigators conducting federally funded research do not need IRB approval for actions taken in response to the threat of COVID-19 as long as those actions are for public health or clinical treatments purposes rather than research, according to a new guidance from the Office for Human Research Protections (OHRP). Read More